Tests IBI362 injections in adults with sleep apnea and obesity
Tests weekly IBI362 injection against placebo in adults with obstructive sleep apnea and obesity.
Plain-language title generated from the registry record
Registry title: A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate-to-severe obstructive sleep apnea and a BMI of 28 kg/m2 or more. People on or off PAP therapy can join.
- Age
- 18 years or older
- Sex
- All
- Disease stage
- Obstructive sleep apnea with an apnea-hypopnea index (AHI) of 15 events/hour or more on a sleep test (polysomnography) at screening.
- Earlier treatment
- People using PAP therapy must have used it for at least 3 consecutive months and plan to continue. People not using PAP must be unable or unwilling to use it and have not used it for at least 4 weeks before screening.
- Biomarker or test result
- BMI of 28.0 kg/m² or more at screening; AHI of 15 events/hour or more on polysomnography.
Main reasons for not taking part
- Type 1 or type 2 diabetes
- Past or planned sleep apnea surgery, or major ear, nose or throat surgery that may still affect breathing
- Significant face or skull abnormalities that may affect breathing
- Obesity hypoventilation syndrome or daytime high carbon dioxide levels
- Weight change of more than 5% through diet and exercise alone in the 12 weeks before screening
Read by machine on 12 November 2026.
Where in China
- Peking University Third HospitalBeijing, ChinaContact: tianpei hongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Trial code
- NCT06931028
- Record updated
- 29 June 2025
- Original description
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg/m2. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of IBI362 in Chinese Subjects With Moderate-to-Severe Obstructive Sleep Apnea and BMI≥28 kg/m2 (GLORY-OSA)
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg/m2. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
Inclusion: For PAP s: Subjects who have received positive airway pressure (PAP) therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study; For non-PAP s:Subjects who are unable or unwilling to undergo PAP therapy. PAP must not have been used for at least 4 weeks prior to screening; For all subjects:; Age ≥18 years at the time of signing informed consent; Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour; Body mass index (BMI) ≥28.0 kg/m² at screening.
Exclusion: Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study; Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study For all subjects：; Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline; Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study; Have achieved a >5% change in body weight through diet and exercise alone for at least 12 weeks prior to screening; Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM); Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia; Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator; For PAPs：; Have significant craniofacial abnormalities that may affect breathing at baseline.